ACON URINALYSIS REAGENT STRIPS

Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)

ACON LABORATORIES CO.

The following data is part of a premarket notification filed by Acon Laboratories Co. with the FDA for Acon Urinalysis Reagent Strips.

Pre-market Notification Details

• Device ID: K061559
• 510k Number: K061559
• Device Name: ACON URINALYSIS REAGENT STRIPS
• Classification: Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
• Applicant: ACON LABORATORIES CO. 4139 GARDENDALE CENTER # 101 San Antonio, TX 78229
• Contact: Martin O'connor
• Correspondent: Martin O'connor; ACON LABORATORIES CO. 4139 GARDENDALE CENTER # 101 San Antonio, TX 78229
• Product Code: CDM
• Subsequent Product Code: CEN
• Subsequent Product Code: JIL
• Subsequent Product Code: JIN
• Subsequent Product Code: JIO
• Subsequent Product Code: JIR
• Subsequent Product Code: JJB
• Subsequent Product Code: JMA
• Subsequent Product Code: JMT
• Subsequent Product Code: JRE
• Subsequent Product Code: LJX
• CFR Regulation Number: 862.1785 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-05
• Decision Date: 2006-08-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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